Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-29 @ 1:43 PM
Study NCT ID:
NCT06269757
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-30
First Post:
2024-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Program for ITB Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058745', 'term': 'Iliotibial Band Syndrome'}], 'ancestors': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-29', 'studyFirstSubmitDate': '2024-02-14', 'studyFirstSubmitQcDate': '2024-02-14', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee injury and Osteoarthritis Outcome Score Physical Short-Form (KOOS-PS) Score', 'timeFrame': 'Month 6', 'description': 'The KOOS-PS4 contains seven items: rising from bed, putting on socks/stockings, rising from sitting, bending to floor, twisting/pivoting on your injured knee, kneeling and squatting. Participants indicate the degree of difficulty they face in performing the items, from "none" to "extreme." A final global score, from 0 (no problems) to 100 (extreme problems), is produced for the scale. Lower scores indicate greater physical function.'}, {'measure': 'Visual Analogue Scale (VAS) Score', 'timeFrame': 'Month 6', 'description': 'Pain is rated on a 10-point scale, from 0 (no pain) to 10 (worst possible pain). The total score is the response; lower scores indicate less pain.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Iliotibial Band Syndrome']}, 'descriptionModule': {'briefSummary': 'Patients with diagnosed iliotibial band (ITB) syndrome indicated for non-operative management will be randomized to individualized exercise program or standard physical therapy over the course of 3 months to determine any possible difference in clinical outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of ITB syndrome\n* Age 18-65\n* Ability to comply with a standardized physical therapy protocol\n* Willing and able to provide consent\n\nExclusion Criteria:\n\n* Patients at any increased risk of falls or at increased risk from harm due to falling, including issues with vertigo, osteoporosis, or a history of past falls\n* Patient otherwise deemed at increased risk from this investigational rehabilitation program by their referring surgeon or physical therapist\n* Patients who are pregnant'}, 'identificationModule': {'nctId': 'NCT06269757', 'briefTitle': 'Exercise Program for ITB Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Efficacy of an Individualized Exercise Program for Iliotibial Band Syndrome: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': '23-01514'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Individualized Exercise Program', 'description': 'Patients with diagnosed ITB syndrome indicated for non-operative management who are assigned to an individualized exercise program.\n\nDuration of therapy will be approximately 3 months. Patients will be followed for 6 months to assess longitudinal outcomes.', 'interventionNames': ['Behavioral: Individualized Exercise Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Physical Therapy', 'description': 'Patients with diagnosed ITB syndrome indicated for non-operative management who are assigned to receive standard physical therapy.\n\nDuration of therapy will be approximately 3 months. Patients will be followed for 6 months to assess longitudinal outcomes.', 'interventionNames': ['Behavioral: Standard Physical Therapy']}], 'interventions': [{'name': 'Individualized Exercise Program', 'type': 'BEHAVIORAL', 'description': 'The individualized exercise program involves an initial 2D individual running evaluation designed for runners of all ages and abilities, to help improve performance and prevent injury. During the assessment patients receive a one-on-one evaluation with an exercise physiologist that includes:\n\n* Running analysis;\n* Training program review;\n* Strength and flexibility assessment;\n* Review of running video;\n* Personalized final report.', 'armGroupLabels': ['Individualized Exercise Program']}, {'name': 'Standard Physical Therapy', 'type': 'BEHAVIORAL', 'description': 'Standard of care physical therapy for ITB band syndrome involves exercises designed to target structural weaknesses such as hip abductor weakness. Typical exercises include but are not limited to hip flexor stretches, side lying hip abduction, figure 4 bridges, lateral walks with exercise bands, and side planks.', 'armGroupLabels': ['Standard Physical Therapy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Samy Shelbaya', 'role': 'CONTACT', 'email': 'Samy.Shelbaya@nyulangone.org', 'phone': '517-575-5522'}], 'overallOfficials': [{'name': 'Guillem Gonzalez-Lomas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will not be shared outside of NYULH.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}